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14-Day Repeated Dose Toxicity and Genotoxicity Studies of cimicifuga heracleifolia Komarov water extract

14-Day Repeated Dose Toxicity and Genotoxicity Studies of Ci...

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亚洲实验动物学会联合会（AFLAS）第三次会议暨中国实...

作者： Jong-Rhan Kim Ji-Ran You Seung-Hyun Kim Euna Kwon Yun-Soon Kim Eun-Young Cho Jung-Hee Yoon Soon-Duk Lee Yoon-Mi Hwang Hye-Jung Jeong Dae-Young Seok Jung-Gi Kim Hyun-Il Won Ja-June Jang Doo-Hyun Jeong Hee-Chan Kim Byeong-Cheol Kang Kook-Hyun Lee Jeong-Hwan Che Clinical Research Institute Seoul National University Hospital Seoul National University College of Medicine Seoul 110-744KOREA

＜正＞cimicifuga heracleifolia Komarov（CH） is used traditionally as a herbal remedy for many ***,published literature suggests that large doses of cimicifuga racemosa might be associated with ***,its long-term toxicity was not evaluated *** study was performed to evaluate 14-day repeated dose toxicity（RDT） and genotoxicity of CH extract according to the USNTP protocol and GLP guideline. To determine the appropriate dosage of CH extract administration,14-days RDT study were performed.14-days repeated dose study was performed to dosage levels of 0.125,0.25,0.5,1 and 2g/kg/day in F344/N *** test substance-related effect were observed in some criteria included mortality;clinical signs;body weight changes;urinalysis,organ weight,gross findings and histopathological findings. In reverse mutation assay of CH extract using Salmonella typhimurium TA98,TA100,TA102,TA1535 and TA1537,test substance was diluted to 5 dosage levels of 312.5,625,1,250,2,500 and 5,000μg/plate with D.D.W..Each tester strain was exposed to the test item with and without metabolic activation *** extract might not have reverse mutagenicity under the condition of this study. Chromosome aberration test of CH extract was performed to evaluate its clastogenic potential in Chinese Hamster Lung fibroblast（CHL） cell *** test substance was diluted to 3 dosage levels of 2,500,1,250,625fig/*** were exposed to test items for 6 or 24 hours in the absence of metabolic activation system,or for 6 hours in the presence of metabolic activation *** was no statistically significant increase in the number of structural or numeric aberrant metaphases at any dose both in the presence and absence of metabolic activation. A micronucleus test o{ CH extract was performed using ICR *** test substance was orally administered to 3 groups of 8-week old male ICR mice at dosage levels of 2,1,and 0.5g/kg *** 3 *** male mice were used in each test *** a

关键词： Good Laboratory Practice(GLP) cimicifuga heracleifolia water extract Korea National Toxicology Program

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